MAUDE Adverse Event Report: BAUSCH + LOMB BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number BLIS-X1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.Upon completion of investigation, a follow-up report will be submitted.

Event Description

Reportedly, immediately after implanting an intraocular lens, a hole in the posterior capsule was discovered.There was spontaneous posterior capsule rupture.The lens was removed without incision enlargement ,or sutures, and replaced with a lens of a different model and diopter.Unplanned vitrectomy was performed.

Manufacturer Narrative

Although requested, the device was not returned for evaluation.Additional information was also requested, and not received.The lot number was not provided.And therefore, a device history record (dhr) review could not be performed.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Possible causes that could have contributed to this event are: use of not enough viscoelastic, loading techniques, or injecting the iol too fast.Based on the available information, user related factors could have contributed to this event.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman st.; rochester NY 14609
• MDR Report Key: 10892322
• MDR Text Key: 217926433
• Report Number: 0001313525-2020-00181
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: K131958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BLIS-X1
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVISTA INTRAOCULAR LENS; ENVISTA INTRAOCULAR LENS
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR